ReGen Anu RHEO™

Amniotic Fluid Matrix Products

ReGen Anu RHEO™

Project Description

Introduction to ReGen Anu RHEO™

ReGen Anu RHEO™ amniotic ﬂuid matrix products are aseptically prepared, minimally manipulated human tissue allografts for homologous use. ReGen Anu RHEO™ is intended to supplement or replace damaged or inadequate connective tissue. Amniotic ﬂuid is the clear to slightly yellowish ﬂuid that surrounds a baby in the uterus. It acts as cushion against hard blows to protect the baby and also helps to regulate the temperature as well. Amniotic ﬂuid is a rich source of nutrients, cytokines, and growth factors that are required for fetal development and maturation. ReGen Anu RHEO™ is a perfect match for synovial ﬂuid in joints and exhibits anti-scarring and anti-adhesion in addition to anti-inﬂammatory properties.

ReGen Anu RHEO™ is processed from donated human tissue from full term deliveries according to the American Association of Tissue Banks (AATB) standards, and is regulated as a human cell, tissue, or cellular or tissue-based product (HCT/P) under 21 CFR Part 1271 and Section 361 of the Public Health Service Administration.

Advantages of ReGen Anu RHEO™ Over Corticoid Steroid Injections

Corticosteroid injections have been used for a very long time. Their anti-inﬂammatory and pain relief properties have made its use a common practice within the medical community. Corticosteroid injections have been shown to be eﬀective in decreasing the inﬂammation and pain of ligament injuries for up to 8 weeks; however, these same properties lead to destruction of cartilage as mentioned above. Simply, the body heals via inﬂammation, cortisone inhibits inﬂammation and healing by disrupting the three characteristic phases: inﬂammatory, proliferative and remodeling.

Amniotic ﬂuid has very similar characteristics to the synovial ﬂuid that is present in the joints. The natural lubrication and anti-inﬂammatory properties help to create an ideal environment for your body to help the proliferation and remodeling of the damaged tissue via the native stem cells present in the body.

What Are the Clinical Benefits?

Typically used for minimally invasive treatment of damaged or inadequate tissue. Amniotic ﬂuid (AF) possesses anti-inﬂammatory, anti-microbial and regenerative properties that make it attractive for use in clinical applications.

Why Would Physicians Be Interested?

ReGen Anu RHEO™ amniotic ﬂuid matrix products provide the extracellular matrix needed for the inﬁltration, attachment and proliferation of cells required for the repair of damaged tissue. Amniotic ﬂuid may reduce scarring, ﬁbrosis, and adhesions in surgical and wound sites. It may also promote tissue regeneration by providing an anti-microbial and anti-inﬂammatory environment at surgical and wound sites.

Procurement Process

All birth tissue products are obtained from C-section deliveries from normal, full-term pregnancies. Donors that consent to use of their birth tissues are carefully screened prior to the use of their tissues in manufacturing.

Comprehensive medical and social histories of the donors are obtained and tissues are procured, processed, and tested in accordance with standards established by the AATB and FDA requirements to minimize potential risks of disease transmission to recipients. Infectious disease testing is performed at a certiﬁed laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493.

All products are tested post-sterilization to demonstrate the absence of bacterial and fungal pathogens and are non-pyrogenic. All testing results are reviewed by the Medical Director of Anu Life Sciences (15491 SW 12th Street, STE 408, Sunrise, FL 33326, 888-963-7881) prior to release of product.